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Virtual Clinical Trials: The New Normal for Stakeholder’s Experience Transformation

Virtual Clinical Trials: The New Normal for Stakeholder’s Experience Transformation
June 22, 2020

Co-authored by: GS Gopalkrishnan

The COVID-19 pandemic has put the clinical trial space on a stand-still because of the fear of cross infection. The disease has imposed serious threats on the continuity of ongoing studies and for initiating new clinical trials.  

So, in this time of public health emergency, the Virtual Clinical Trials are the best solution as they use digital technologies to handle data.  The following table highlights the key differences between traditional and virtual clinical trials:

Parameters

Traditional – Multi Centric Trials

Virtual Clinical Trials

Study Operations:

Centralized Clinical Research Centre

Virtual Site Connected online

Site:

Multiple locations with investigators and diagnostic facilities

Multiple virtual locations connected online with lab, investigators & subjects

Subject:

Personal assessment

No human interaction with patients

Clinical Data:

Data collected locally in EDC/ paper CRF

Direct online data collection

Regulatory aspects

For the management of clinical research in the prevailing COVID-19 scenario, the US FDA has published new guidelines (in April 2020) on the conduct of clinical trials of medical products. FDA insists on the use of virtual-assessments (e.g., phone contact, virtual visit, alternative location for assessment, including local labs or imaging centres) over in-person assessments. It is interesting to note that for ongoing trials, the FDA has allowed initiating virtual clinical trial visits for monitoring patients without contacting them to remove an apparent immediate threat or to safeguard the well-being of the subjects.

Drivers for Virtual & Hybrid Clinical Trials

  • Digital Advancements
  • Central Labs with connected equipment
  • Advances in Telemedicine/ Telehealth
  • Use of RWE/RWD
  • Centralized Regulatory Control
  • Better monitoring
  • Increased patient participation and boosting cycle times
  • Inclination to use wearable devices
  • Expedited outcomes like- trial result, regulatory submission, and publications

Virtual Clinical Trials Platform

Virtual trials revolve around electronic processes, and if implemented correctly they offer a much better patient-centred approach. The right strategy for implementation of a digital virtual clinical trials platform is key for its successful run. However, with the current maturity level of regulations, it becomes difficult to deploy such digital platforms.

The need of the hour is a platform that can support a wide-range of technologies, such as AI for BI related analytics & mining, ML for pattern recognition, RPA/IPA led advanced automation of repetitive/predictive tasks, NLP/NLG for analysis of text, language and voice generation, and blockchain for decentralized information sharing. Large amounts of data should be collected through MDM in a cloud based Clinical Data Warehouse and the site staff and patients can be given training through virtual reality & gamification. Study physicians, nurses and pharmacists can provide support to the subjects via videoconferencing/telecommuting.

Sufficient security measures must be established for the network which may include virtual sites with the labs, patient wearable data recordings with site, nursing notes and other parameters with clinical data warehouse.

Ideal Virtual Clinical Trial Candidates

  • Phase IV or marked drug performance studies involving large sample size, global locations
  • Phase III confirmation trials, ready to accept digital endpoints
  • Post Marketing Surveillance (Safety Data recorder)
  • Few Pharmacokinetics (PK)/ Pharmacodynamics (PD) studies

Use Cases for Virtual Clinical Trials

Some of the common use cases are highlighted below:

Use Case – 1: Planning and Timely Alliance Clinical Research Team during Operations

A digital platform for clinical research must offer modules so that team can collaborate as-and-when needed during the trial process with sufficient transparency. Visual analytics-enabled dashboards on connected devices, workflow notification with online review/approval of documents and chatbots should help in planning and subsequent operations. Cross-functional reports in a standard template will enhance overall work efficiency. Project Plan, Statistical Analysis Plan (SAP), Monitoring Plan, Data Management Plan (DMP), Data Coding Plan and Safety Data Handling Plan should be auto-generated based on in-house data, industry trends and regulatory guidelines. All planning documents for virtual trials must have a component that emphasizes the authenticity, credibility, and quality of remote data collection procedures. 

Use Case – 2:  Smart Protocol Design 

The concept of virtual trials starts from the point of inception of protocol design. The trial design must be clear on the method of data collection. The selected virtual clinical trials platform must leverage the latest technologies (mobile apps, wearable monitoring devices, etc.) and should be capable of social media listening. This also indicates that the seamless integration across the spectrum and the capability of handling various complicated data types (including unstructured, continuous,  contextual data, etc.) should be inbuilt.  Well defined sections should be incorporated as a part of trial design. For example, e-informed consent process, e-patient screening, e-handling of safety data, e-measurement of clinical endpoints, e-SAP, etc. 

Use Case – 3:  Identification of Virtual Site, Subject Recruitment/Enrolment

Existing method of site identification, subject recruitment and their enrollment in traditional clinical trials has to be tweaked for virtual trials. Selected sites must have advanced facilities with specialists and qualified staff as-well-as relevant experience in the particular therapeutic area. Site staff including investigator must have time to take-up the commitment and attitude to adopt latest technology. Once everything is in place, what matters is the availability of necessary infrastructure, along with electronic connectivity. Most apt site would also mean ‘a directly proportional relationship’ in terms of prospective subject recruitment/enrolment based on past performance. The platform must have a checklist and KPI based scoring to rank the most suitable sites for the virtual trial under consideration.

Use Case – 4:  Data Management, Data Analytics & Data Governance

With complete respect to patent privacy, the platform should be capable of merging and effectively utilizing both active data from clinical research and passive data from personal health devices and healthcare facilities.

The platform must offer metadata repository, preferably in-line with Clinical Data Acquisition Standards Harmonization (CDASH)/ Clinical Data Interchange Standards Consortium (CDISC) to define basic standards for data collection for virtual clinical trials. Based on the study protocol, complete automation of the rules must be pre-established within the platform-modules for data profiling, hierarchy listing, cleansing, standardization, parsing, matching/mapping and de-duplication for both structured and unstructured data.  In traditional trials data quality is mainly assured through SDV and queries. However, for virtual trials, AI-driven risk-based data cleaning strategies can be utilized for issue identification, prevention, and resolution.

Use Case –5:  Going Study Site-less: Direct-To-Patient Trials

The want for an alternative to traditional clinical trials is long overdue because the overall clinical research procedure is too complicated due to stringent regulations. The concept of going site-less in clinical trials can be implemented if data from the point of care can be somehow utilized successfully to gauge clinical output. To begin with, trials which are conducted on marketed drugs can be a good starting point. To avoid post-production changes, flexible libraries with standard information capable of accepting multiple study designs can help to go site-less. IP drug supply, sourcing and logistics must be carefully handled with the digital platform. Ability for data masking for blinded studies should also pre-installed as a part of study configuration with automatic inputs from e-SAP.

Based on our experience and readiness in this area, we believe we are not far away from a technology-centric customized platform that can enable virtual clinical trials.